Status:
COMPLETED
Autologous Peripheral Nerve Grafts Into the Substantia Nigra of Subjects With PD Undergoing Deep Brain Stimulation
Lead Sponsor:
Craig van Horne, MD, PhD
Collaborating Sponsors:
University of Kentucky
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
By doing this study, the investigators hope to learn provide safety data that can be used to generate a larger phase III clinical trial. If successful, it would promote the development of a new treatm...
Detailed Description
This pilot study is designed to test the safety and feasibility of the implantation of the subject's own peripheral nerve tissue into an area of the brain called the substantia nigra. Only subjects wh...
Eligibility Criteria
Inclusion
- Elected to have DBS Surgery
- Parkinson's Disease for 5 years or more
- Ages 40-75
Exclusion
- Have previously undergone PD surgery or any intracranial surgery
- Unwilling to delay taking PD medications during the study
- Unable to follow the directions of the study team
- Unable to attend all study visits
- Have participated in previous clinical studies and received an investigational product within 30 days of screening
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01833364
Start Date
April 1 2013
End Date
September 1 2015
Last Update
March 9 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40475
2
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536